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Institutional Review Board (IRB)
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Stem Cell Research Oversight (SCRO)
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Original page: https://research.ucr.edu/ori/committees/irb-clin/wirb.aspx
Western Institutional Review Board (WIRB) is an independent, commercial IRB that provides services for UCR. WIRB has been contracted to act as one of UCR’s IRBs to review, approve and monitor our Phase I - IV Clinical Trials.
UCR and WIRB have established an agreement whereby WIRB agrees to assume IRB oversight for some research conducted at or by UCR. The following describes the scope of research activities for which UCR will agree to allow WIRB to assume IRB oversight, and outlines the procedures for obtaining permission to submit to WIRB. UCR has sole discretion on a study-by-study basis for allowing WIRB to assume oversight.
SPA and ORI
The lifecycle of pre-trial administration activities leading to the start of a clinical trial involves several key steps, some of which should occur simultaneously, to prevent undue delays. This includes obtaining IRB approval and execution of a Clinical Trials Agreement (CTA). The information provided on this webpage is meant to be used in tandem with the Sponsored Programs Administration (SPA) required submissions. As soon as it appears likely that UCR will participate in a clinical trial, please initiate the process with SPA and also begin to prepare to work with the Office of Research Integrity (ORI) for an IRB submission to WIRB.
Procedures for Obtaining WIRB IRB Oversight of a Project
The process outlined here is only for investigator-initiated clinical trials. Sponsor-initiated trials will depend on the negotiated Clinical Trials Agreement (CTA) between the PI and the Sponsoring entity or IND holder. See the SPA site for more information on initiating the CTA process.
WIRB will review research on behalf of UCR only with notification that the UCR Office of Research Integrity (ORI) & IRB has cleared the study for WIRB oversight. UCR IRB staff will screen the application for eligibility for WIRB IRB oversight. Screening involves use of a checklist to ensure that:
- The research fits the definition of a clinical trial (Phase I – IV)
- The investigator(s) is (are) UCR Principal Investigators (PI) with research privileges.
- All investigators and staff conducting research have completed the Collaborative Institutional Training Initiative (CITI) online course. Investigators and staff conducting clinical trials are also required to take GCP training, either through CITI or by providing a copy of their ACRP or SoCRA certification. Required training must be renewed every 3 years.
- This training is only available individuals with a UCR email account
- For IRB-Clin specific training, you will want to select the modules that specifically pertain to “Biomedical Research Investigators” and “Good Clinical Practice Course, US FDA Focus”
- For additional information on accessing CITI courses, please see our Instructions for Accessing the CITI program.
Important to know: If your research is not a clinical trial (Phase I-IV), WIRB review is not required. Instead, UCR’s IRB-Clin may review your study.